(301 days)
Not Found
No
The summary describes a standard x-ray imaging system and does not mention any AI or ML capabilities in its intended use, device description, or performance studies.
No
The device is an imaging system (O-arm® Imaging System) used for diagnostic purposes by capturing 2D fluoroscopic and 3D x-ray images of anatomic structures. It does not provide any therapeutic function.
Yes
Explanation: The device is described as an "Imaging System" that provides 2D and 3D information of anatomic structures, and the intended use includes where a physician benefits from this information. This information is used for diagnostic purposes (e.g., verifying patient position, assessing anatomical structures).
No
The device description explicitly states it is a "mobile x-ray system" consisting of an "x-ray O-arm® Stand" and a "mobile view station," clearly indicating the presence of hardware components beyond just software.
Based on the provided information, the O-arm® Imaging System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is a mobile x-ray system for 2D and 3D imaging of anatomic structures and objects with high x-ray attenuation. This involves imaging within the body (in vivo), not testing samples outside the body (in vitro).
- Device Description: The description details an x-ray system with an x-ray generator, detector, and viewing station. This is consistent with an imaging device used on a patient, not a device for analyzing biological samples.
- Input Imaging Modality: The input is x-ray, which is used for imaging the body directly.
- Anatomical Site: The anatomical sites mentioned are within the body (bony anatomy, metallic objects).
- Intended User / Care Setting: The intended user is a physician in surgical theaters, which aligns with an intraoperative imaging system used on a patient.
IVD devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. The O-arm® Imaging System does not perform these functions.
N/A
Intended Use / Indications for Use
The O-arm® Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems.
The O-arm® Imaging System is a portable x-ray system designed for 2D fluoroscopic and 3D imaging for high contrast objects and anatomic structures.
The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems. The O-arm® Imaging System may be used with medical charged particle radiation therapy systems for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.
Product codes (comma separated list FDA assigned to the subject device)
LINE, OXD, LHN, OXO
Device Description
The O-arm® Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D fluoroscopic imaging. The system consists of two parts: the x-ray O-arm® Stand (comprising x-ray generator, flat dynamic x-ray detector, and the x-ray control user interface) and the mobile view station (comprising the image processors, a user interface for image and patient handling, and viewing monitor).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray, 2D fluoroscopic, 3D imaging
Anatomical Site
anatomic structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician, intraoperative applications in surgical theaters
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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JUN 17 2010
792564
Attachment E - 510(k) Summary
Date prepared June 10, 2010
510(k) Owner Medtronic Navigation, Inc. (Littleton)
Phone: 978-698-6045 Fax: 763-367-8304
Contact Seth Kuzdzal, RA/QA Manager
Trade name O-Arm Imaging System
Common name Mobile x-ray system
Classification Name: System, X-ray, mobile name Regulation: 21 CFR 892.1720 Product codes LINE OXD
- O-arm® Imaging System, which was cleared to market in 510(k)s Predicate device K050996 and K060344.
Device The O-arm® Imaging System is a mobile x-ray system which provides description 3D imaging as well as 2D fluoroscopic imaging.
The system consists of two parts: the x-ray O-arm® Stand (comprising x-ray generator, flat dynamic x-ray detector, and the x-ray control user interface) and the mobile view station (comprising the image processors, a user interface for image and patient handling, and viewing monitor).
Indications for The O-arm® Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a use physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems.
P. I ನ
K092564 Medtronic Navigation O-arm Imaging System Medironic O-am Imaging System
page 30 of 31
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Comparison to the predicate
device
| | Modified
O-arm® | Predicate
O-arm® |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | Mobile x-ray imaging
designed for 2D
fluoroscopic and 3D
imaging and is intended
to be used where a
physician benefits from
2D and 3D information of
anatomic structures and
objects with high x-ray
attenuation such as bony
anatomy and metallic
objects.
Compatible with certain
Image Guided Surgery
Systems. | The O-Arm™ Imaging
System is designed for
2D Fluoroscopic and 3D
imaging for
intraoperative
applications in surgical
theaters, particularly for
orthopedic applications.
The O-Arm™ Imaging
System is compatible
with certain Image
Guided Surgery Systems. |
| Technology | Same as predicate O-
arm®. | Mobile cone-beam x-ray
system with isocentric
motion options.
O-arm® allows 3D image
reconstruction from 360°
sweep of x-ray source
and detector within
closed gantry. |
| Imaging | Same as predicate O-
arm® with image quality
improvement. | 2D Fluoroscopy and 3D
Imaging. |
| Other
characteristics | Same as predicate O-
arm®. | Sterile accessories,
wireless mouse, etc. |
Conclusion
.
Based on design characteristics and imaging performance, the modified O-arm® Imaging System is substantially equivalent to the predicate Oarm® Imaging.
K092584 Medtronic Navigation O-arm Imaging System Medtronic O-arm Imaging System
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three heads in profile, connected by a flowing ribbon-like shape. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Seth Kuzdzal RA/QA Manager Medtronic Navigation, Inc., Littleton 300 Foster Street LITTLETON MA 01460
NOV 1 4 2011
Re: K092564
Trade/Device Name: O-arm® Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system, mobile Regulatory Class: II Product Code: LHN and OXO Dated: June 10, 2010 Received: June 11, 2010
Dear Mr. Kuzdzal:
This letter corrects our substantially equivalent letter of June 17, 2010.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please Note: CDRH does not evaluate information related to contact liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely Yours,
Muthal POThm far
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K892564
.
ﻤﺎﺷ
Device Name: O-arm® Imaging System
Indications for Use
The O-arm® Imaging System is a portable x-ray system designed for 2D fluoroscopic and 3D imaging for high contrast objects and anatomic structures.
The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems. The O-arm® Imaging System may be used with medical charged particle radiation therapy systems for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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